Blood acquisition suspension system

ABSTRACT

A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable to cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/457,872, filed Jul. 17, 2006, now U.S. Pat. No. 7,927,291 which is adivisional of U.S. patent application Ser. No. 10/737,660, filed Dec.16, 2003, now U.S. Pat. No. 7,351,212 which claims the benefit of U.S.Provisional Application No. 60/436,952, filed Dec. 30, 2002, all ofwhich are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to bodily fluid sampling devicesand more specifically, but not exclusively, concerns an integrated bodyfluid sampling device that is adapted to temporarily remove and reapplythe test strip to the incision site.

General Fluid Testing

The acquisition and testing of bodily fluids is useful for many purposesand continues to grow in importance for use in medical diagnosis andtreatment and in other diverse applications. In the medical field, it isdesirable for lay operators to perform tests routinely, quickly, andreproducibly outside of a laboratory setting, with rapid results and areadout of the resulting test information. Testing can be performed onvarious bodily fluids, and for certain applications is particularlyrelated to the testing of blood and/or interstitial fluid. Such fluidscan be tested for a variety of characteristics of the fluid, or analytescontained in the fluid, in order to identify a medical condition,determine therapeutic responses, assess the progress of treatment, andthe like.

General Test Steps

The testing of bodily fluids basically involves the steps of obtainingthe fluid sample, transferring the sample to a test device, conducting atest on the fluid sample, and displaying the results. These steps aregenerally performed by a plurality of separate instruments or devices.

Acquiring—Vascular

One method of acquiring the fluid sample involves inserting a hollowneedle or syringe into a vein or artery in order to withdraw a bloodsample. However, such direct vascular blood sampling can have severallimitations, including pain, infection, and hematoma and other bleedingcomplications. In addition, direct vascular blood sampling is notsuitable for repeating on a routine basis, can be extremely difficult,and is not advised for patients to perform on themselves.

Acquiring—Incising

The other common technique for collecting a bodily fluid sample is toform an incision in the skin to bring the fluid to the skin surface. Alancet, knife, or other cutting instrument is used to form the incisionin the skin. The resulting blood or interstitial fluid specimen is thencollected in a small tube or other container or is placed directly incontact with a test strip. The fingertip is frequently used as the fluidsource because it is highly vascularized and therefore produces a goodquantity of blood. However, the fingertip also has a large concentrationof nerve endings, and lancing the fingertip can therefore be painful.Alternate sampling sites, such as the palm of the hand, forearm,earlobe, and the like, may be useful for sampling and are less painful.However, they also produce lesser amounts of blood. These alternatesites therefore are generally appropriate for use only for test systemsrequiring relatively small amounts of fluid or if steps are taken tofacilitate the expression of the bodily fluid from the incision site.

Various methods and systems for incising the skin are known in the art.Exemplary lancing devices are shown, for example, in U.S. Pat. Nos. Re35,803, issued to Lange, et al. on May 19, 1998; 4,924,879, issued toO'Brien on May 15, 1990; 5,879,311, issued to Duchon et al. on Mar. 9,1999; 5,857,983, issued to Douglas et al. on Jan. 12, 1999; 6,183,489,issued to Douglas et al. on Feb. 6, 2001; 6,332,871, issued to Douglaset al. on Dec. 25, 2001; and 5,964,718, issued to Duchon et al. on Oct.12, 1999. A representative commercial lancing device is the Accu-ChekSoftclix® lancet.

Expressing

Patients are frequently advised to urge fluid to the incision site, suchas by applying pressure to the area surrounding the incision to milk orpump the fluid from the incision. Mechanical devices are also known tofacilitate the expression of bodily fluid from an incision. Such devicesare shown, for example, in U.S. Pat. Nos. 5,879,311, issued to Duchon etal. on Mar. 9, 1999; 5,857,983, issued to Douglas et al. on Jan. 12,1999; 6,183,489, issued to Douglas et al. on Feb. 6, 2001; 5,951,492,issued to Douglas et al. on Sep. 14, 1999; 5,951,493, issued to Douglaset al. on Sep. 14, 1999; 5,964,718, issued to Duchon et al. on Oct. 12,1999; and 6,086,545, issued to Roe et al. on Jul. 11, 2000. Arepresentative commercial product that promotes the expression of bodilyfluid from an incision is the Amira AtLast® blood glucose system.

Sampling

The acquisition of the produced bodily fluid, hereafter referred to asthe “sampling” of the fluid, can take various forms. Once the fluidspecimen comes to the skin surface at the incision, a sampling device isplaced into contact with the fluid. Such devices may include, forexample, systems in which a tube or test strip is either locatedadjacent the incision site prior to forming the incision or is moved tothe incision site shortly after the incision has been formed. A samplingtube may acquire the fluid by suction or by capillary action. Suchsampling systems may include, for example, the systems shown in U.S.Pat. Nos. 6,048,352, issued to Douglas et al. on Apr. 11, 2000;6,099,484, issued to Douglas et al. on Aug. 8, 2000; and 6,332,871,issued to Douglas et al. on Dec. 25, 2001. Examples of commercialsampling devices include the Roche Compact®, Amira AtLast®, GlucometerElite®, and Therasense FreeStyle® test strips.

Testing General

The bodily fluid sample may be analyzed for a variety of properties orcomponents, as is well known in the art. For example, such analysis maybe directed to hematocrit, blood glucose, coagulation, lead, iron, etc.Testing systems include such means as optical (e.g., reflectance,absorption, fluorescence, Raman, etc.), electrochemical, and magneticmeans for analyzing the sampled fluid. Examples of such test systemsinclude those in U.S. Pat. Nos. 5,824,491, issued to Priest et al. onOct. 20, 1998; 5,962,215, issued to Douglas et al. on Oct. 5, 1999; and5,776,719, issued to Douglas et al. on Jul. 7, 1998.

Typically, a test system takes advantage of a reaction between thebodily fluid to be tested and a reagent present in the test system. Forexample, an optical test strip will generally rely upon a color change,i.e., a change in the wavelength absorbed or reflected by dye formed bythe reagent system used. See, e.g., U.S. Pat. Nos. 3,802,842; 4,061,468;and 4,490,465.

Blood Glucose

A common medical test is the measurement of blood glucose level. Theglucose level can be determined directly by analysis of the blood orindirectly by analysis of other fluids such as interstitial fluid.Diabetics are generally instructed to measure their blood glucose levelseveral times a day, depending on the nature and severity of theirdiabetes. Based upon the observed pattern in the measured glucoselevels, the patient and physician determine the appropriate level ofinsulin to be administered, also taking into account such issues asdiet, exercise, and other factors.

In testing for the presence of an analyte such as glucose in a bodilyfluid, test systems are commonly used which take advantage of anoxidation/reduction reaction which occurs using an oxidase/peroxidasedetection chemistry. The test reagent is exposed to a sample of thebodily fluid for a suitable period of time, and there is a color changeif the analyte (glucose) is present. Typically, the intensity of thischange is proportional to the concentration of analyte in the sample.The color of the reagent is then compared to a known standard whichenables one to determine the amount of analyte present in the sample.This determination can be made, for example, by a visual check or by aninstrument, such as a reflectance spectrophotometer at a selectedwavelength or a blood glucose meter. Electrochemical and other systemsare also well known for testing bodily fluids for properties onconstituents.

Testing Difficulties

Performing the above-discussed steps can be difficult for patients,especially for patients with limited hand dexterity, such as theelderly. Typical lancing devices require the user to manually cock thelancet. As should be appreciated, manual cocking of the device may bedifficult for those with hand dexterity problems. In a typicalprocedure, after cocking the firing mechanism, the patient fires thelancet at the skin in order to form an incision in the skin. Once asufficient amount of fluid collects as a droplet from the incision inthe skin, the patient has to position a test strip over the incisionsite such that the test strip contacts and absorbs a sufficient amountof the fluid for testing. Usually, these droplets of fluid are quitesmall, and patients, especially ones with poor hand motor control, mayexperience great difficulty in positioning the test strip so as tocollect an adequate sample from an individual droplet. As should beappreciated, a patient can become quickly frustrated by this procedureand, consequently, they may perform the test less often or may even quittesting altogether. Moreover, the pressure applied against the skin bythe test strip during sampling can cause the incision to close, therebyprematurely cutting off the fluid supply. If the fluid supply from theincision is cut off too soon, an insufficient amount of the fluid may becollected on the test strip for testing.

Thus, needs remain for further contributions in this area of technology.

SUMMARY OF THE INVENTION

One aspect the present invention concerns a bodily fluid sampling devicethat temporarily removes a fluid collection means from skin so as topromote fluid formation from an incision in the skin.

Another aspect concerns a method for sampling bodily fluid. The methodincludes forming an incision in the skin with an integratedlancet/sampling device. The device is temporarily withdrawn from theskin to promote fluid formation from the incision. The device is thenreapplied proximal to the fluid or in contact with the skin in order tocollect the fluid.

Still yet another aspect concerns a bodily fluid sampling device able toautomatically cock a firing mechanism before lancing the skin.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a bodily fluid sampling device accordingto one embodiment of the present invention.

FIG. 2 is an enlarged, perspective view of the FIG. 1 device.

FIG. 3 is a cross sectional view of the FIG. 1 device forming anincision into skin.

FIG. 4 is a cross sectional view of the FIG. 1 device temporarilyretracted from the skin.

FIG. 5 is a cross sectional view of the FIG. 1 device configured tocollect fluid from the incision.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

The present invention generally concerns an integrated skin lancingdevice that reduces the number of steps involved in forming, collecting,and testing a bodily fluid sample from an incision. More specifically,the device is operable to automatically cock the lancing mechanism, andthe device is further operable to temporarily lift the device fromcontact with the skin and reposition the device over the incision sitein order to collect a fluid sample. By temporarily lifting the devicefrom the skin, no pressure is applied to the skin by the device, whichcould potentially close the incision and limit the fluid supply for thesample. In one embodiment, the device includes an electric motor thatautomatically cocks the lancing mechanism and temporarily lifts a fluidcollection means from the skin. It is contemplated that, in anotherembodiment, a purely mechanical system can be used to temporarily liftthe fluid collection means.

An integrated bodily fluid sampling device 30 according to oneembodiment, among others, of the present invention will now be describedwith reference to FIGS. 1-2. As depicted in FIG. 1, device 30 includes asampling end portion 32 and an actuation end portion 34. The samplingend portion 32 includes an integrated lancet/sampling device 36, aholder 38 for device 36, and a depth control mechanism 40. Device 36 isconfigured to lance an incision into the skin, collect a bodily fluidsample from the incision, and analyze the fluid sample. In device 36, alancet or blade 42 for forming the incision is housed in a casing 44.For illustration purposes, so that the lancet 42 can be seen in FIG. 1,lancet 42 is shown in an extended state. Normally, when the lancet 42 isnot lancing the skin, the lancet 42 is retracted inside the casing 44.During lancing, the casing 44 is pressed against the skin to form areference surface on which the penetration depth of the lancet 42 isbased. As device 36 is further pressed against the skin, the casing 44slides relative to the lancet 42 such that the lancet 42 is exposed,thereby lancing the incision into the skin. Device 36 further includes atest strip or media 46 for analyzing the fluid sample. The test strip 46can analyze fluid through such means as optical (e.g., reflectance,absorption, fluorescence, Raman, etc.), electrochemical, and/or magneticanalysis, to name a few. In one embodiment, the test strip analyzesfluid optically through a chemical reagent. A capillary channel isformed between the casing 44 and the lancet 42, which draws fluid ontothe test strip 46 via capillary action. As previously mentioned, theholder 38 holds device 36 during lancing. The depth control mechanism 40is used to control and change the penetration depth of the lancet 42into the skin. For a further discussion of these components in thesampling end portion 32 as well as their function, please refer tocommonly owned U.S. patent application Ser. No. 10/330,724 entitled“PRECISION DEPTH CONTROL LANCING TIP”, filed on Dec. 27, 2002, which ishereby incorporated by reference in its entirety. As will be appreciatedfrom the discussion below, the bodily fluid sampling device 30 accordingto the present invention can be modified to be used in conjunction withother types of lancing and/or sampling devices.

FIG. 2 illustrates an enlarged view of the actuation portion 34 of thesampling device 30. So that the actuation portion 34 can be easilyviewed, FIGS. 1 and 2 show the device 30 without a housing. However, itshould be appreciated that device 30 can include a housing in order toprotect the components of device 30 from the outside environment. Asshown, the actuation portion 34 includes a support structure 48 thatsupports a motor 50 as well as a firing mechanism 52. The firingmechanism 52 is used to fire the integrated lancet/sampling device 36 inorder to lance the skin, and the motor 50 is used to cock the firingmechanism 52 as well as to temporarily retract device 36 after lancing.The support structure 48 in the illustrated embodiment has first 54 andsecond 56 support arms that are connected together through an actuationguide member 58 such that support structure 48 is shaped in the form ofa “C”. Opposite guide member 58, the first 54 and second 56 support armsrespectively have first 60 and second 62 motor mounts in which the motor50 is mounted. The illustrated motor 50 has a generally cylindricalshape, but it is contemplated that motor 50 can have other shapes. Asillustrated, motor mounts 60 and 62 each have a hollow cylindrical shapeso as to coincide with the cylindrical shape of the motor 50 such thatmotor 50 is able to fit inside mounts 60 and 62. However, it should beappreciated that motor mounts 60 and 62 can be shaped differently so asto coincide with the shape of differently shaped motors.

In the illustrated embodiment, the motor 50 includes a reversibleelectric motor, but it should be appreciated that motor 50 can includeother types of motors, such as a pneumatic motor. Moreover, in anotherembodiment in which the motor 50 is non-reversible, the device 30 caninclude a transmission configured to reverse the outputted force fromthe motor 50. In one embodiment, the motor 50 is powered by an internalpower source, such as a battery or a fuel cell, but it is contemplatedthat the motor 50 can be powered in other manners, such as externallythrough an electrical outlet. As depicted in FIGS. 1 and 2, the motor 50has a drive shaft with a drive gear 64 that extends through the firstsupport arm 54. A reduction gear 66, which is rotatably mounted to thefirst support arm 54, operatively engages the drive gear 64 of the motor50. The firing mechanism 52 includes a guide rod 68 that extends betweenthe first 54 and second 56 support arms along longitudinal axis L of thedevice 30. As illustrated, the guide rod 68 is rotatably mounted to thefirst 54 and second 56 support arms via first 70 and second 72 bushings,respectively. At the first support arm 54, the guide rod 68 operativelyengages the reduction gear 66 such that the motor 50 is able to rotatethe guide rod 68. A drive thread or coil 74, which winds in a helicalpattern around the guide rod 68, is attached to the guide rod 68 at bothends through bushings 70 and 72 in one embodiment. In anotherembodiment, the ends of the drive thread 74 are directly attached to theguide rod 68. As noted above, the guide rod 68 is operatively engaged tothe motor 50 via the reduction gear 66. Both the guide rod 68 and thedrive thread 74, in the illustrated embodiment, rotate in unison as themotor 50 rotates the reduction gear 66. It is contemplated that inanother embodiment only the drive thread 74 operatively engages thereduction gear 66 such that the guide rod 68 remains stationary as thedrive thread 74 rotates.

Referring to FIG. 2, the firing mechanism 52 further includes a drivemember 76 that engages the drive thread 74 and an actuation member 78that is coupled to holder 38. A spring (or elastic means) 80 is coupledbetween the drive member 76 and the actuation member 78. Among its manyfunctions, the spring 80 is used to fire the lancet 42 from device 36.During cocking, the motor 50 via drive thread 74 drives the drive member76 towards the actuation member 78 such that the spring 80 is compressedtherebetween. As will be described in greater detail below, thepotential energy stored by the compressed spring 80 is then used to firethe actuation member 78, which in turn extends the lancet 42 from theintegrated lancet/sampling device 36.

As depicted, the drive member 76 has a rod engagement portion 82 that isslidably received along the guide rod 68. In FIG. 2, the rod engagementportion 82 is positioned inside the drive thread 74 and has one or morethread engaging arms 84 extending therefrom that engage the drive thread74. In the illustrated embodiment, the rod engagement portion 82 has apair of L-shaped thread engaging arms 84 positioned on opposite sides ofthe rod engagement portion 82, and the thread engaging arms 84 extendthrough the drive thread 74. It should be appreciated that the rodengagement portion can include more or less thread engaging arms 84 thanis shown. Through the engagement between the drive thread 74 and thethread engaging arms 84, the motor 50 is able to move the drive member76 along longitudinal axis L in either a driving direction D or aretraction direction R. For example, rotating the drive thread 74 in aclockwise fashion moves the drive member 76 in direction D, and rotatingthe drive thread 74 in a counterclockwise fashion moves the drive member76 in direction R. It should be appreciated, however, that the drivethread 74 in other embodiments can be coiled in an opposite fashion suchthat the drive thread 74 can be rotated in clockwise direction to movethe drive member 76 in direction R and counterclockwise to move thedrive member 76 in direction D.

The drive member 76 further includes a spring engagement portion 86 andan actuation member engagement portion 88. As shown, the spring 80 isattached to the spring engagement portion 86, and the thread engagingarms 84 attach the rod engagement portion 82 to the spring engagementportion 86. In the illustrated embodiment, the spring engagement portion86 is ring shaped so as to fit around the drive thread 74. One or moreguide arms 90 connect the spring engagement portion 86 to the actuationmember engagement portion 88. As shown, the drive member 76 in theillustrated embodiment has a pair of guide arms 90 that are disposed onopposite sides of the drive member 76. At least one of the guide arms 90is constructed to include a guide tab 92 that is slidably receivedbetween a pair of guide rails 94 that extend from the guide member 58 ofthe support structure 48. It, however, should be understood that device30 can include more or less guide arms 90 and guide rails 94 than isshown. The guide rails 94 in conjunction with the guide tab 92 directthe drive member 76 to move along the longitudinal axis L and preventthe drive member 76 from rotating in response to the rotation of thedrive thread 74. Referring to FIG. 2, portion 88 of the drive member 76defines a spring opening 96 through which the spring 80, the drivethread 74, and the guide rod 68 extend. Around opening 96 the drivemember 76 defines one or more engagement notches 98 in which theactuation member 78 is slidably received.

With reference to FIG. 1, the actuation member 78 includes one or more(and in the illustrated embodiment a pair of) slide arms 100 that areslidably received in the engagement notches 98 defined in the drivemember 76. Each of the slide arms 100 has a stop tab 102 located at theend proximal the drive member 76. As shown, the stop tab 102 has abeveled insertion surface 104 that aids in slidably attaching theactuation member 78 to portion 88 of the drive member 76. At the secondsupport arm 56, the slide arms 100 extend through slide arm openings 106that are defined in the second support arm 56 such that the slide arms100 are able to move in a sliding fashion through openings 106. The endsof the slide arms 100 that are connected to the holder 38 are connectedtogether via a connection member 108. In the support structure 48, theslide arms 100 are connected to together through a cocking flange 110.In the illustrated embodiment, the cocking flange 110 is ring shaped anddefines a thread opening 112 through which the drive thread 74 extends.

As shown in FIG. 2, the spring 80 is attached to the cocking flange 110such that the spring 80 is coupled between the spring engagement portion86 of the drive member 76 and the cocking flange 110 of the actuationmember 78. During cocking of the device 30, the motor 50 rotates thedrive thread 74 so that the drive member 76 is driven toward the cockingflange 110 of the actuation member 78. As the drive member 76 is driventowards flange 110, a pair of cocking arms 114, which extend from thesecond support arm 56 in a parallel arrangement with respect to thelongitudinal axis L, support the cocking flange 110 against the forceapplied by the spring 80. It should be appreciated that device 30 inother embodiments can include one or more cocking arms 114. The cockingarms 114 have support tabs 116 that face one another in order to supportthe cocking flange 110 during cocking. Proximal the drive member 76, thecocking arms 114 have drive member engagement surfaces 118 with anangled or beveled shape. Similarly, the drive member 76 has cocking armengagement surfaces 120 that are likewise beveled or angled to coincidewith the shape of the drive member engagement surfaces 118. As the drivemember 76 is driven towards the cocking arms 114 during cocking, thecocking arm engagement surfaces 120 spread the cocking arms 114 apartsuch that the cocking flange 110 is released. Upon flange 110 beingreleased, the compressed spring 80 drives the cocking flange 110 awayfrom the drive member 76, thereby driving the integrated lancet/samplingdevice 36 to lance the skin. As depicted in FIG. 2, the cocking arms 114further have reengagement surfaces 122 that are angled in order to allowthe cocking flange 110 to reengage the support tabs 116.

The operation of the integrated bodily fluid sampling device 30according to one embodiment will now be described with reference toFIGS. 1, 2, 3, 4, and 5. FIGS. 3, 4, and 5 illustrate the relativeposition of the sampling device 36 in relation to skin S during thesampling technique according to one embodiment of the present invention.In the illustrated embodiment, device 30 has a housing 124 that iscoupled to the support structure 48, and as shown, the housing 124includes a skin contact portion 126, which surrounds the sampling device36, so as to position device 30 with the skin S. In one form, the skincontact portion 126 is cylindrical in shape, but it is should beappreciated that the skin contact portion 126 can be shaped differently.Moreover, it is contemplated that in other embodiments the skin contactportion 126 can be entirely or partially omitted such that the personusing the fluid sampling device 30 manually holds device 30 in positionover the skin S. The skin contact portion 126 in the illustratedembodiment is sized so as to not to apply force to the skin that canclose incision I once formed.

Initially, the cocking flange 110 of the firing mechanism 52 engages thesupport tabs 116 of the cocking arms 114, as is shown in FIG. 1. In onorder to initiate lancing, the user positions device 36 either incontact with or proximal to the skin S. In the embodiment illustrated inFIG. 3, the user presses the skin contact portion 126 against the skin Sso as to position device 36. To cock the firing mechanism 52, asdepicted in FIG. 2, the motor 50 via reduction gear 66 rotates the drivethread 74 so that the drive member 76 is driven in driving direction Dalong longitudinal axis L towards the cocking flange 110 of theactuation member 78. Cocking can be initiated by the user through aswitch on device 30 that activates the motor 50 and/or automaticallythrough a controller in the device 30. It should be appreciated that themotor 50 can be activated in other manners. Since the cocking flange 110is engaged with the cocking arms 114, the spring 80 in the firingmechanism 52 becomes compressed as the drive member 76 is driven indirection D. When the drive member 76 is further driven in direction D,the stop tabs 102 of the actuation member 78 disengage from theactuation member engagement portion 88 of the drive member 76 such thatthe slide arms 100 slide within the engagement openings 98 of the drivemember 76. Eventually, as the spring 80 becomes further compressed bythe drive member 76, the arm engagement surfaces 120 on the drive member76 engage the drive member engagement surfaces 118 on the cocking arms114 such that the cocking arms 114 are pried apart from one another.Once arms 114 are sufficiently bent away from one another, the supporttabs 116 on the cocking arms 114 disengage from the cocking flange 110.

As soon as the cocking flange 110 is disengaged, the compressed spring80 expands so as to drive the actuation member 78 in direction D towardsthe skin. After the firing mechanism 52 is fired, the motor 50 in oneembodiment stops driving the drive member 76. In one form, a timer isused to control the operation of the motor 50. Nevertheless, it iscontemplated that the motor 50 can be controlled in other manners, suchas through a controller and sensors. When the actuation member 78 isfired, the actuation member 78 presses the casing 44 of the integratedlancet/sampling device 36 against the skin, and the lancet 42 inside thecasing 44 slides relative to the casing 44 so as to extend from thecasing 44, thereby lancing the incision I in the skin S (FIG. 3). Thedepth control mechanism 40 controls the penetration depth of the lancet42. Once the incision of the proper depth is formed, a retractionmechanism, such as a leaf spring in device 36, retracts the lancet 42back inside the casing 44. In addition, the forward progression of theactuation member 78 in direction D is stopped in one embodiment by thestop tabs 102 contacting the actuation member engagement portion 88 onthe drive member 76. In another embodiment, the movement of theactuation member 78 is stopped by the cocking flange 110 hitting thesecond support arm 56.

To prevent the pressure applied by the casing 44 from prematurelyclosing the incision, thereby limiting the fluid supplied from theincision, the bodily fluid sampling device 30 according to oneembodiment of the present invention temporarily lifts the integratedlancet/sampling device 36 in direction R from the skin, as is shown inFIG. 4. Afterwards, the bodily fluid sampling device 30 reapplies thecasing 44 of device 36 against the skin or positions device 36 proximalthe skin such that the integrated lancet/sampling device 36 is able tocollect a fluid sample from the incision, as is illustrated in FIG. 5.As should be appreciated, this sampling technique according to thepresent invention increases the size of the fluid sample by notrestricting the fluid flow from the incision I. In one embodiment, thebodily fluid sampling device 30 lifts the integrated lancet/samplingdevice 36 for two (2) seconds before reapplying device 36 against theskin. However, it should be appreciated that device 36 can betemporarily lifted from the skin for different time intervals. Totemporarily remove device 36 from the skin S, the motor 50 in FIG. 2 isreversed such that the drive thread 74 is rotated in an oppositedirection (as compared to when cocking the firing mechanism), therebymoving the drive member 76 in retraction direction R. For example, thedrive thread 74 can be rotated in a clockwise direction to move drivemember 76 in direction D and can be rotated in a counterclockwisedirection so as to move the drive member 76 in direction R. As should beappreciated, the drive member 76 in other embodiments can be advanced indirection D and retracted in direction R by rotating the drive thread 74in an opposite fashion. While the drive member 76 is driven in directionR, the stop tabs 102, which engage the drive member 76, also pull theactuation member 78 in direction R. When the actuation member 78 ismoved in direction R, device 36 is likewise moved in direction R,thereby lifting the casing 44 of device 36 from the skin S (FIG. 4). Inone embodiment, the integrated lancet/sampling device 36 is lifted asmall distance from the skin, and in particular, device 36 is lifted 1mm from the skin. It should be appreciated, however, that device 36 canbe retracted at different distances from the skin.

Once device 36 has been lifted from the skin for a short period of time,the motor 50 is then again reversed so as to drive the drive member 76in direction D. The force applied by the drive member 76 against thespring 80 is transferred to the actuation member 78 so that device 36 ismoved in direction D towards the skin (FIG. 5). When the integratedlancet/sampling device 36 contacts the skin S or is positioned at thedesired distance from the skin S, the motor 50 can be deenergized. Thebodily fluid F that has formed as a droplet from the incision I in theskin S is drawn via capillary action into the capillary cavity formed inthe casing 44 and deposited onto the test strip 46 in device 36 so thatthe fluid sample can be analyzed.

To reset the bodily fluid sampling device 30 for future samplecollection, the motor 50 drives the drive member 76 in the retractiondirection R such that the actuation mechanism 78 is likewise pulled inthe retraction direction R. As the actuation mechanism 78 is pulled indirection R, the cocking flange 110 engages the reengagement surfaces122 on the cocking arms 114, and the arms 114 are pried apart so thatthe cocking flange 110 reengages the support tabs 116 on the cockingarms 114. Once the bodily fluid sampling device 30 is reset, the firingmechanism 52 can be again cocked and fired in the manner as describedabove.

It is contemplated that, in another embodiment, a purely mechanicaldevice can be used to accomplish the sampling technique as describedabove in which the integrated lancet/sampling device is temporarilyremoved and reapplied to the skin. In one form, a hydraulic and/orpneumatic cylinder is used to dampen or slow the mechanical movement inwhich the integrated lancet/sampling device is temporarily removed andreapplied.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

What is claimed is:
 1. A body fluid sampling device, comprising: a housing configured to contact tissue; an integrated lancing-sampling device including a casing and a lancet for lancing an incision in the tissue slidably received in the casing, wherein the casing defines a sampling cavity for drawing body fluid from the incision, wherein the integrated lancing-sampling device is disposed inside the housing, wherein the casing of the integrated lancing-sampling device forms a reference surface upon which penetration depth of the lancet is based when the casing is pressed against the tissue, wherein the casing and the lancet of the lancing-sampling device are configured to be removed from the housing as a single disposable unit; and a positioner mechanism configured to retract the casing of the integrated lancing-sampling device from contact with the tissue after cutting the incision to a retracted position to promote flow of body fluid from the incision while the housing remains in contact with the tissue, the positioner mechanism being configured to subsequently move the integrated lancing-sampling device from the retracted position to a collection position where the body fluid is collected, wherein the casing of the integrated lancing-sampling device is positioned closer to the tissue at the collection position than at the retracted position.
 2. The device of claim 1, further comprising a firing mechanism coupled to the integrated lancing-sampling device for firing the integrated lancing-sampling device.
 3. The device of claim 2, further comprising: wherein the firing mechanism includes a spring configured to fire the lancet; and means for automatically cocking the spring of the firing mechanism.
 4. The device of claim 3, further comprising: wherein the means for automatically cocking the spring of the firing mechanism includes a motor; and the firing mechanism including a holder in which the integrated lancing-sampling device is received, a guide rod operatively engaged with the motor, the guide rod including a drive thread winding in a helical pattern around the guide rod, a drive member engaging the drive thread, an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms, one or more cocking arms engageable with the cocking flange to hold the actuation member in place during cocking, the spring being coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the guide rod, and wherein the drive member includes one or more arm engagement surfaces configured to release the cocking flange from the cocking arms to fire the lancet via the spring.
 5. The device of claim 4, wherein the motor includes a reversible motor with a drive shaft configured to rotate in a first direction during retraction of the integrated lancing-sampling device and in a second direction during extension of the integrated lancing-sampling device.
 6. The device of claim 1, further comprising a depth control mechanism coupled to the integrated lancing-sampling device to adjust the penetration depth of the lancet.
 7. The device of claim 1, wherein the integrated lancing-sampling device includes a spring to retract the lancet from the incision.
 8. The device of claim 1, wherein the integrated lancing-sampling device includes a reference surface against which the tissue is pressed during lancing to control penetration depth of the lancet.
 9. The device of claim 1, wherein the positioner mechanism includes: a reversible motor with a drive shaft configured to rotate in a first direction during retraction of the integrated lancing-sampling device and in a second direction during extension of the integrated lancing-sampling device, the drive shaft including a drive thread winding in a helical pattern around the drive shaft; a holder in which the integrated lancing-sampling device is received; a drive member engaging the drive thread; an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms; one or more cocking arms engageable with the cocking flange to hold the actuation member in place during cocking; and a spring coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the drive shaft.
 10. A body fluid sampling device, comprising: an integrated lancing-sampling device including a lancet configured to lance an incision in tissue; a firing mechanism coupled to the integrated lancing-sampling device, the firing mechanism including a spring configured to fire the lancet; a cocking mechanism coupled to the spring configured to place the spring in a cocked state, wherein the cocking mechanism includes an electric motor configured to deform the spring for storing potential energy in the spring when in the cocked state; wherein the integrated lancing-sampling device includes a casing; wherein the motor is configured to retract the integrated lancing-sampling device from contact with the tissue after cutting the incision and subsequently move the integrated lancing-sampling device to a collection position where the body fluid is collected; and wherein the casing of the integrated lancing-sampling device is located closer to the tissue at the collection position than when retracted.
 11. The device of claim 10, wherein the firing mechanism includes: a holder in which the integrated lancing-sampling device is received; a guide rod operatively engaged with the motor, the guide rod including a drive thread winding in a helical pattern around the guide rod; a drive member engaging the drive thread; an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms; one or more cocking arms engageable with the cocking flange to hold the actuation member in place during cocking; a spring coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the guide rod; and wherein the drive member includes one or more arm engagement surfaces configured to release the cocking flange from the cocking arms to fire the lancet via the spring.
 12. The device of claim 10, wherein the motor includes a reversible motor with a drive shaft configured to rotate in a first direction during retraction of the integrated lancing-sampling device and in a second direction during extension of the integrated lancing-sampling device.
 13. A method, comprising: placing a housing of a body fluid sampling device against tissue; lancing tissue by firing a lancet of an integrated lancing-sampling device while the housing remains in contact with the tissue, wherein the lancet of the integrated lancing-sampling device is slidably received in a casing, wherein the casing contacts the tissue during said lancing, wherein the casing defines a sampling cavity for drawing body fluid from an incision; retracting the casing of the integrated lancing-sampling device from contact with the tissue to a retracted position to promote flow of body fluid from the incision after said lancing, wherein the housing remains in contact with the tissue during said retracting; moving the integrated lancing-sampling device from the retracted position to a collection position after said retracting the casing, wherein the housing remains in contact with the tissue during said moving, wherein the casing of the integrated lancing-sampling device is located closer to the tissue at the collection position than at the retracted position; and collecting the body fluid by drawing the body fluid from the incision into the sampling cavity of the casing while the housing remains in contact with the tissue.
 14. The method of claim 13, further comprising: wherein the body fluid sampling device includes a reversible motor with a drive shaft, wherein the drive shaft includes a drive thread winding in a helical pattern around the drive shaft; rotating the drive shaft in a first direction during said retracting; and rotating the drive shaft in a second direction during said moving the integrated lancing-sampling device.
 15. The method of claim 13, further comprising: wherein the body fluid sampling device includes a motor, a holder in which the integrated lancing-sampling device is received, a guide rod operatively engaged with the motor, the guide rod including a drive thread winding in a helical pattern around the guide rod, a drive member engaging the drive thread, an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms, one or more cocking arms engageable with the cocking flange to hold the actuation member in place during cocking, and a spring coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the guide rod, and wherein said lancing the tissue includes cocking the spring by compressing the spring between the drive member and the actuation member with the motor at least until the cocking flange engages the cocking arms to hold the spring in a cocked state, and releasing the spring by driving one or more arm engagement surfaces of the drive member with the motor to release the cocking flange from the cocking arms.
 16. A method, comprising: cocking a firing mechanism to a cocked state by compressing a spring of the firing mechanism with an electric motor; firing a lancet with the firing mechanism by releasing the spring from the cocked state; wherein the lancet is incorporated into an integrated lancing-sampling device in which the lancet is slidably received in a casing of the integrated lancing-sampling device, wherein the casing defines a sampling cavity for drawing body fluid from an incision; drawing the body fluid from the incision into the sampling cavity of the integrated lancing-sampling device; further comprising placing a housing of a body fluid sampling device against tissue, wherein the body fluid sampling device includes the firing mechanism; keeping the housing in contact with the tissue during said firing; retracting the casing of the integrated lancing-sampling device from contact with the tissue to a retracted position to promote flow of body fluid from the incision after said firing, wherein the housing remains in contact with the tissue during said retracting; and moving the integrated lancing-sampling device from the retracted position to a collection position after said retracting the casing, wherein the housing remains in contact with the tissue during said moving.
 17. The method of claim 16, further comprising: wherein the firing mechanism includes a holder in which the lancet is received, a guide rod operatively engaged with the motor, the guide rod including a drive thread winding in a helical pattern around the guide rod, a drive member engaging the drive thread, an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms, one or more cocking arms engageable with the cocking flange to hold the actuation member in place during said cocking, and the spring coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the guide rod, and wherein said cocking includes compressing the spring between the drive member and the actuation member with the motor at least until the cocking flange engages the cocking arms to hold the spring in the cocked state, and wherein said firing includes releasing the spring by driving one or more arm engagement surfaces of the drive member with the motor to release the cocking flange from the cocking arms. 